Evaluation of Lifestyle Modification on Cardiovascular Risk

NCT05417698 | Active Not Recruiting

• 1 other identifier: RIO 035-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes to examine the independent and combined effects of an 8-week home-based, equipment-free HIIT exercise intervention with/without Mediterranean diet through ghrelin-mediated alteration in overweight and obese metabolic women to improve cardiovascular-risk related markers and metabolic risk factors.

Conditions

Metabolic Syndrome; Menopause; Cardiovascular Diseases; Obesity; Type2diabetes

Keywords

Ghrelin; Postmenopause

Outcome Measures

Primary Outcomes (5)

• Visceral adiposity index (VAI)

  Assessed at baseline and post-intervention (Week 1 and Week 8). VAI calculated based on their waist circumference, BMI, triglycerides and HDL cholesterol levels. Waist circumference will be recorded in centimetres. BMI will be combined based on weight (kilograms) and height (metres) as kg/m\^2. Triglycerides and HDL cholesterol levels will be assessed from fasting blood collected from the antecubital vein via venepuncture. Triglycerides and HDL will be recorded in mmol/L.

  Baseline to 8 weeks

• Inflammatory markers

  Assessed at baseline and post-intervention (Week 1 and Week 8). IL-6, CRP, IL-10, TNF-α will be assessed from fasting blood collected from the antecubital vein via venepuncture.

  Baseline to 8 weeks

• Blood lipid levels

  Assessed at baseline and post-intervention (Week 1 and Week 8). Triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol will be assessed from fasting blood collected from the antecubital vein via venepuncture. All blood lipids will be recorded in mmol/L.

  Baseline to 8 weeks

• Blood pressure

  Assessed at baseline and post-intervention (Week 1 and Week 8). Systolic and diastolic blood pressure will be obtained from the participant's left arm after resting for at least 10 minutes. Blood pressure will be recorded in mmHg.

  Baseline to 8 weeks

• Insulin resistance index (HOMA-IR)

  Assessed at baseline and post-intervention (Week 1 and Week 8). Calculated based on blood glucose levels (mmol/L) and insulin (pmol/L) from fasting blood collected from the antecubital vein via venepuncture.

  Baseline to 8 weeks

Secondary Outcomes (1)

• Circulatory levels of ghrelin

  Baseline to 8 weeks

Study Arms (3)

Exercise only (Ex only)

EXPERIMENTAL

Participants in the "Exercise only" group will be performing home-based, equipment-free HIIT exercise for 20 minutes, 3 times a week for the duration of the 8-weeks, achieving ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals. Participants are also required to exercise at least 17 out of 20 on the Rate of Perceived Exertion (RPE) scale.

Other: Exercise Only (Ex only)

Exercise and Mediterranean Diet (Ex + MedDiet)

EXPERIMENTAL

Participants in Ex+MedDiet arm will be required to adhere to a non-caloric restrictive Mediterranean diet throughout the 8-weeks according to a Mediterranean diet booklet provided by the researcher. In brief, diet encompasses a focus on minimally processed food, incorporating a wide variety of fruits, vegetables, legumes and wholegrains, whilst utilising olive oil as the main source of fat. They will be encouraged to eat more oily and white fish, with moderate consumption of nuts, poultry and dairy products, and low consumption of red/processed meat and alcohol. Participants in this group will also be performing home-based, equipment-free HIIT exercise for 20 minutes, 3 times a week for the duration of the 8-weeks, achieving ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals. Participants are also required to exercise at least 17 out of 20 on the Rate of Perceived Exertion (RPE) scale.

Other: Exercise and Mediterranean Diet (Ex + MedDiet)

Control

NO INTERVENTION

Participants will be asked to maintain their diet and physical activity levels throughout the 8 weeks.

Interventions

Exercise Only (Ex only) OTHER

Unsupervised, home-based, equipment-free high-intensity interval training of 20 minutes exercise performed 3 times a week, for a duration of 8-weeks. Participants will perform exercises to their own suitability in a progressive manner throughout the 8-weeks. Exercises will be exerted at least ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals, as well as at least 17 out of 20 Rate of Perceived Exertion on the Borg Scale.

Exercise only (Ex only)

Exercise and Mediterranean Diet (Ex + MedDiet) OTHER

Participants in Ex+MedDiet arm adhere to a non-caloric restrictive Mediterranean diet throughout the 8-weeks comprising of a diet encompassing a focus on minimally processed food, incorporating a wide variety of fruits, vegetables, legumes and wholegrains, whilst utilising olive oil as the main source of fat. They will be encouraged to eat more oily and white fish, with moderate consumption of nuts, poultry and dairy products, and low consumption of red/processed meat and alcohol. Participants will also perform unsupervised, home-based, equipment-free high-intensity interval training of 20 minutes exercise performed 3 times a week, for a duration of 8-weeks. Participants will perform exercises to their own suitability in a progressive manner throughout the 8-weeks. Exercises will be exerted at least ≥80% of predicted heart rate maximum (HRmax; 220-age) during the high-intensity intervals, as well as at least 17 out of 20 Rate of Perceived Exertion on the Borg Scale.

Exercise and Mediterranean Diet (Ex + MedDiet)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Participants \>45-65 years of age
• Body mass index (BMI) \>25.0 - 35.0
• Postmenopausal (with spontaneous amenorrhea for the last 12 months)
• Healthy (no known diseases)
• Physically inactive (IPAQ score - category I and not engaged in at least 60 min/week of structured exercise during the previous 6 months)
• Generally well enough to exercise.

You may not qualify if:

• Abnormal ECG
• Current smokers
• Current or history of substance abuse and/or excess alcohol intake
• Cardiovascular disease
• Cancer
• Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome
• Kidney disease
• Liver disease
• Pancreatitis
• On hormone therapy for \<6 months
• Prescribed anti-hypertensive or beta-blocker medication

Sponsors & Collaborators

• Swansea University: lead

Study Sites (1)

Swansea University

Swansea, sa2 8pp, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Obesity

Interventions

Exercise; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised-controlled

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: June 14, 2022
• Study Start: August 15, 2022
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

GB (1)